Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (ACCOMPLISH)

This study has been terminated.

(The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.)

Sponsor:

Novartis

ClinicalTrials.gov Identifier:

NCT00170950

First Posted: September 15, 2005

Last Update Posted: May 17, 2011

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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event [ Time Frame: For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) ]

Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event [ Time Frame: For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])] ]

Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event

Measure Description

Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).

Time Frame

For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Intent-to-treat population: All randomized patients by assigned treatment group

Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event [Units: Percentage of Patients with an Event]

8.6

10.3

No statistical analysis provided for Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event

3. Secondary:

Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke [ Time Frame: For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]) ]